PReventing Emerging infections through Vaccine EffectiveNess Testing—COVID (Project PREVENT)

About this Study

The primary objective of this project is:
1) To evaluate post-introduction effectiveness of a complete schedule of SARS-CoV-2 vaccine in preventing laboratory-confirmed symptomatic COVID-19 among HCP.
Secondary objectives include:
1) Estimating the post-introduction effectiveness of SARS-CoV-2 vaccines in preventing severe disease among those with laboratory-confirmed symptomatic COVID-19;
2) Identifying differences in vaccine effectiveness by age group and comorbidity categories;
3) Evaluating vaccine effectiveness in various job categories and clinical practice settings;
4) Estimating the comparative effectiveness of different SARS-CoV-2 vaccines or, for vaccines with 2-dose schedules, 1 vs. 2-doses;
5) Comparing health care and COVID-19 testing practices of HCP within specific job groups;
6) Describing quarantine, isolation, repeat testing, and return-to-work practices among vaccinated and unvaccinated HCP tested for COVID-19;
7) Identifying factors associated with the decision to be vaccinated for SARS-CoV-2; and
8) Evaluating provider behavior changes, use of infection mitigation strategies, and decision-making in response to COVID-19 vaccination.

Sponsor Protocol ID:pending
IRB Number:Pending
Actively Enrolling
Observational
Observational/Not Applicable
April 05, 2021
Eligibility Criteria
Both Male and Female
No
No
Yes

Inclusion Criteria
Any employee or volunteer in a participating hospital who was tested for COVID-19 is eligible for inclusion, regardless of their degree of patient exposure or vaccination status. HCP will include all paid and unpaid persons in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including:
• Body substances;
• Contaminated medical supplies, devices, and equipment;
• Contaminated environmental surfaces; or
• Contaminated air.

All employees retained for full data collection will meet either Criteria 1 or Criteria 2 during a period from 14 days prior to their first COVID-19 test to 14 days after that test. Asymptomatic participants will be screened for symptom development, and only those who develop Criteria 1 or 2 symptoms during the surveillance period will be enrolled in the project. Among those tested, a questionnaire will be used to confirm that the employee is eligible for participation. These clinical illness criteria below were developed in consultation with CDC to align with FDA criteria for vaccine clinical trials, but they are subject to revision during project startup activities.
CRITERIA 1. At least ONE of the following respiratory signs/symptoms:
• Shortness of breath or difficulty breathing;
• Cough; or
• Severe respiratory illness with either clinical or radiographical evidence of pneumonia or acute respiratory distress syndrome (ARDS).
OR
CRITERIA 2. At least TWO of the following signs/symptoms:
• Fever (within episode of illness);
• Myalgia;
• New olfactory and taste disorder(s);
• Chills;
• Rigors;
• Headache; or
• Sore throat.
Any person who participated in a COVID-19-related vaccine trial may be included, but detailed information about enrollment and allocation will be required.
Eligible employees can be enrolled more than once (if the employee tested negative during a prior enrollment), but after being enrolled they will be ineligible for a period of 4 weeks after the time of enrollment, and they must have had complete resolution of symptoms from the time of the first episode of testing.

Exclusion CriteriaAny employee who was previously diagnosed with laboratory confirmed COVID-19 infection (RT-PCR, or antigen) will be ineligible (including previous project participants who tested positive during prior participation). Any person unable to confirm test results or vaccine administration using an approved method will also be excluded. Any previously enrolled HCP who did not complete the follow-up survey during a previous enrollment will be ineligible for re-enrollment.

Categories Click category to view its trials.
COVID-19 (Coronavirus)
Participating Locations
University Hospital
Contact Information
Contact Name: Rebekah Peacock
Phone Number: 601-815-3008
Email: rpeacock@umc.edu
Principal Investigator:Nandi, Utsav, M.D.
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